Neurofeedback with direct training of specific brain regions compared to other biofeedback training methods in patients with Attention Deficit Hyperactivity Disorder (ADHD)

ISRCTN	ISRCTN82524080
DOI	https://doi.org/10.1186/ISRCTN82524080
Secondary identifying numbers	N/A

Submission date: 20/01/2010
Registration date: 02/02/2010
Last edited: 02/02/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Renate Drechsler
Scientific

Neumuensterallee 9
Zurich
8032
Switzerland

Email	renate.drechsler@kjpd.uzh.ch

Study information

Study design	Single centre prospective controlled randomised parallel groups intervention study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	http://www.kjpd.uzh.ch/research/focus/focus1/Studien-Neurofeedback.pdf
Scientific title	Specificity of tomographic neurofeedback training compared to other biofeedback training methods in patients with ADHD: A randomised controlled trial.
Study objectives	There is growing evidence that neurofeedback training is an effective treatment method for ADHD, but its specificity and underlying mechanisms still need to be explored. In this study, we investigate specific and unspecific effects of three biofeedback training methods: 1. tomographic neurofeedback, 2. conventional neurofeedback and 3. Electromyogram (EMG) biofeedback.
Ethics approval(s)	The Cantonal Ethical Committee of the Canton of Zurich, Subcommission on psychiatry, neurology, neurosurgery (Kantonale Ethikkommission des Kantons Zürich, Unterkommission für Psychiatrie, Neurologie, Neurochirurgie) approved on the 3rd of October 2008 (ref: E57/2005)
Health condition(s) or problem(s) studied	Attention Deficit Hyperactivity Disorder (ADHD)
Intervention	Interventions consist of three biofeedback-training methods, using the same training software and parallel training protocols: 1. Tomographic neurofeedback allows targeting the frontal brain regions which are most affected in ADHD (lateral and mesial), and train patients to modify their activation within these areas according to specific training protocols. To this end, current densities are computed using the standardized Low Resolution Brain Electromagnetic Tomography (sLORETA) algorithm and fed back visually to the subjects in order to change the activation in the particular Regions of Interest (ROIs). 2. In conventional neurofeedback the signal is fed back from the surface of the scalp by one electrode. 3. In EMG-biofeedback, fine motor regulation is fed back. Duration: 18 double training sessions, over a period of 10-12 weeks. The total follow up time will be 3 months.
Intervention type	Other
Primary outcome measure	1. Clinical ADHD scales (parent-, teacher-, self-report) 2. Neuropsychological tests (subtests from computerised test batteries Test for Attentional Performance [TAP], Child-TAP [Kinder-TAP; KITAP] and D2) 3. Quantitative Electroencephalography (qEEG) and Event-Related Potentials (ERPs) Measured at baseline and 3-month follow-up.
Secondary outcome measures	Quantitative measures of learned control during the biofeedback training. Measured at each training session.
Overall study start date	01/03/2009
Completion date	31/12/2010

Eligibility

Participant type(s)	Patient
Age group	Other
Sex	Both
Target number of participants	80
Key inclusion criteria	1. Diagnosis of ADHD 2. Children (age >8.5) and adults (age >18).
Key exclusion criteria	1. (Severe) psychiatric comorbidity 2. Neurological diseases 3. IQ<80
Date of first enrolment	01/03/2009
Date of final enrolment	31/12/2010

Locations

Countries of recruitment

Switzerland

Study participating centre

Neumuensterallee 9

Zurich
8032
Switzerland

Sponsor information

University of Zurich (Switzerland)
University/education

Department of Child and Adolescent Psychiatry
Neumuensterallee 3-9
Zurich
8032
Switzerland

Website	http://www.kjpd.unizh.ch/index.html
"ROR"	https://ror.org/02crff812

Funders

Funder type

Government

European Union - EU Project (COST-B27 ENOC / C06.0071)

No information available

Department of Health of the Canton of Zurich (Switzerland)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan